FDA recall Z-0734-2022

Product

Azurion systems with software release R2.0.x

Reason for recall

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

Distribution

US Nationwide Distribution

Key facts

Status

Completed

Initiation date

2021-05-26

Report date

2022-03-30

Voluntary/Mandated

FDA Mandated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2022